The dietary supplement industry in the U.S. is growing fast. More people are looking for vitamins, minerals, and other supplements to support their health. If you’re planning to sell supplements, you need to follow strict regulations to make sure your products are safe and legal.
Unlike regular foods or prescription drugs, dietary supplements have their own set of rules. The Food and Drug Administration (FDA) oversees these products, ensuring they meet safety, labeling, and manufacturing standards. If businesses don’t follow these guidelines, they risk fines, product recalls, or being removed from the market.
To help you get started, this guide covers the 10 essential steps for legally selling dietary supplements in the U.S. You’ll learn about FDA requirements, labeling rules, ingredient safety, and best practices to keep your business on the right track.
What Are Dietary Supplements?
Before diving into the requirements, let’s define dietary supplements. According to the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements are products intended to supplement the diet. They can include:
Vitamins & minerals
Herbs & botanicals
Amino acidsEnzymes & probiotics
Other nutritional substances
Understanding this definition is crucial because dietary supplements are regulated differently from conventional foods and prescription drugs.
Key Requirements for Selling Dietary Supplements in the U.S.
To legally market dietary supplements in the U.S., you must comply with FDA regulations and industry best practices. Here are the 10 essential steps you need to follow:
1. Compliance with DSHEA
The DSHEA serves as the foundational regulatory framework for dietary supplements in the U.S. It sets forth essential requirements that manufacturers and distributors must adhere to:
Product Labeling: Dietary supplements must have accurate labeling, including a Supplement Facts panel that provides information about the product’s ingredients and serving size.
Ingredient Safety: Manufacturers are responsible for ensuring the safety of ingredients used in their products. They should not include ingredients that are unsafe or unapproved.
Claims and Statements: Claims made on dietary supplement labels must be truthful and not misleading. They cannot claim to treat or cure specific diseases.
2. Follow FDA Good Manufacturing Practices (GMPs)
The FDA’s Good Manufacturing Practices (GMPs) ensure dietary supplements are produced consistently and meet quality standards. These guidelines cover:
Facility cleanliness & sanitation
Proper ingredient sourcing
Equipment maintenance
Employee training & compliance
Failure to meet GMP requirements can result in product recalls or penalties.
3. Submit a New Dietary Ingredient Notification (NDIN)
If your dietary supplement contains a new ingredient not previously used in the U.S. before October 15, 1994, you must submit a New Dietary Ingredient Notification (NDIN) to the FDA at least 75 days before market launch.
4. Notify the FDA About Your Product
While dietary supplements do not require pre-market FDA approval, manufacturers must notify the FDA within 30 days of launching a product that contains structure/function claims (e.g., “supports immune health”).
5. Ensure Proper Labeling Compliance
Your dietary supplement label must include:
Product name & form (capsule, tablet, powder, etc.)
Net quantity of contents
Supplement Facts panel with ingredient details
Serving size & daily values
Manufacturer’s name & contact information for adverse reaction reporting
Allergen warnings (if applicable)
Labels must be clear and truthful and should not suggest that the product is a drug or a cure for medical conditions.
6. Avoid Disease Claims
Supplements cannot claim to:
- Diagnose medical conditions
- Cure or treat diseases
- Prevent illnesses
Instead, businesses can use approved structure and function claims, such as:
- “Supports immune health” instead of “Prevents infections”
- “Promotes joint flexibility” instead of “Treats arthritis”
7. Implement Quality Control and Testing
To ensure product safety and effectiveness, manufacturers must:
- Verify ingredient identity and potency
- Test for contaminants such as heavy metals and pesticides
- Maintain accurate ingredient concentrations
Regular third-party testing can improve credibility and consumer trust.
8. Report Serious Adverse Events to the FDA
If consumers experience serious side effects from a supplement, manufacturers must report these cases to the FDA. This helps protect public safety and ensures transparency in the industry.
9. Check for Additional State Regulations
Some states have stricter rules for dietary supplements than the federal government. Businesses should check local regulations before distributing products nationwide.
10. Stay Updated on Regulatory Changes
The dietary supplement industry is always evolving. To stay compliant, businesses should:
- Subscribe to FDA and Federal Trade Commission (FTC) updates
- Join industry organizations like the Council for Responsible Nutrition (CRN)
- Consult regulatory experts when launching new products
Final Thoughts on Selling Supplements in the U.S.
Selling dietary supplements in the U.S. is an exciting opportunity, but it comes with strict legal responsibilities. By following FDA regulations, ensuring proper labeling, and maintaining high-quality standards, businesses can build trust with consumers and avoid legal issues.
Understanding these compliance steps will help you confidently enter the market and offer safe, high-quality supplements. For expert guidance on dietary supplement regulations, contact our team today.
